RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran; Enoxaparin

Criteria

Inclusion criteria

Inclusion criteria (selected):

• Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee replacement

• Written Informed Consent

Exclusion criteria

Exclusion criteria (selected):

• Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.

• Active malignant disease or current cytostatic treatment

• Known severe renal insufficiency

• Liver disease expected to have any potential impact on survival, or elevated aspartate aminotransferase (AST) or alanine transaminase (ALT) > 2x upper limit of normal

• Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months

• Pre-menopausal women who are pregnant or nursing, or are of child-bearing pote ntial and are not practising or do not plan to continue practising acceptable me thods of birth control

• Allergy to radio opaque contrast media or iodine, heparins (incl. heparin indu ced thrombocytopenia) or dabigatran

• Contraindications to enoxaparin

• Participation in a clinical trial during the last 30 days